Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy

Stanford University

Status: Withdrawn

Conditions: Prostate Cancer

Treatments: Procedure: Prostatic artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT05415696

IRB-64391

PROS0108 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn if the prostatic artery embolization procedure can reduce urinary tract symptoms in patients with enlarged prostates and prostate cancer.

Full description

PRIMARY OBJECTIVE

1. To evaluate the symptomatic improvement in lower urinary tract symptoms after prostatic artery embolization (PAE)

SECONDARY OBJECTIVES

1. To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual
2. To measure effects of PAE on prostate specific antigen (PSA).
3. To evaluate if PAE reduces the prostate volume and simplifies radiation therapy
4. To evaluate the safety of PAE performed in this patient population

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 40 years and ≤ 90 years old

• Prostate volume ≥ 40 mL and ≤ 300 mL

• Biopsy proven prostate cancer undergoing radiation therapy

• Diagnosis of moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:

  1. IPSS ≥ 12 or dependent on urinary catheterization, or
  2. IPSS Quality of Life (QoL) assessment ≥ 3, and
  3. Qmax ≤ 12 mL/sec

• Ability to understand and willingness to sign the written consent

Exclusion criteria

• Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
• Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than prostatic obstruction, as demonstrated on urodynamic testing
• Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
• Other active urogenital cancer
• Baseline serum creatinine greater than 2 mg/dL
• Evidence of tortuous or atherosclerotic blood vessels
• Coagulation disturbances not normalized by medical treatment
• Allergy to iodinated contrast agents not responsive to steroid premedication regimen

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Prostatic artery embolization (PAE)

Other group

Description:

Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.

Treatment:

Procedure: Prostatic artery embolization